migraine relief

Product NDC
72288-286
11-digit product format
722880286
Labeler code
72288
Product ID
72288-286_26495ff4-57bc-4e28-b04c-d2da16be4c27
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, aspirin, caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA075794
Marketing category
ANDA
Marketing start
2026-09-11
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINEACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26c2088c7a36db…
2026-09-14 22:38:342026-08A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2684e616aacf4f…
2026-08-18 06:07:402026-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
migraine relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCedcc7b4b-1317-4060-b947-8c16effc57422023-02-27WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
basic care migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCa19798b3-1b2e-4e4f-b595-2a156bd52ee52022-07-28WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
topcare migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINETopco Associates LLC9163ecfe-6493-46eb-a08d-b4134d84b0ab2022-06-28WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
dg health migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Inc673d42d8-b484-4232-bc91-19d83db635502022-06-07WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-286-27722880286271 BOTTLE in 1 CARTON (72288-286-27) / 80 TABLET, FILM COATED in 1 BOTTLE (72288-286-00) 1 bottle2026-09-11NoNoCurrent